NCT01257243已完成3 期
Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment
EMS1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Reduction/improvement of cough symptoms
研究概览
简要总结
The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.
详细描述
STUDY DESIGN
- Open-label, superiority, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 3 visits (days 1, 2 and 7)
- Reduction cough symptoms
- Adverse events evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
- •Cough score superior to 3.
排除标准
- •Pregnancy or risk of pregnancy.
- •Fever above 38º C.
- •Patients with bacterial infections of the upper respiratory tract.
- •Any pathology or past medical condition that can interfere with this protocol.
研究组 & 干预措施
DRUG 1
Experimental
Syrup of oxomemazine, guaifenesin and potassium iodate
干预措施: Syrup of oxomemazine, guaifenesin and potassium iodate (Drug)
DRUG 2
Active Comparator
Syrup of guaifenesin
干预措施: Syrup of guaifenesin (Drug)
结局指标
主要结局
Reduction/improvement of cough symptoms
时间窗: DAY 7
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
次要结局
- Tolerance(DAY 7)
研究者
研究点 (1)
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